QA Shop Floor Specialist


Posted: 07/05/2022 Job Number: 21008538

Job Description

Work Schedule: 12 hour shifts with split week including one weekend day, Sun - Wed/2nd shift (4pm - 4am) or Wed - Sat/2nd shift (4pm - 4am).
Onsite position.

Project Description:
  • The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with the Client's policies, standards, procedures, and Global cGMP.
  • Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.
  • Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology, and other departments to effectively accomplish responsibilities make improvements and resolve issues.
  • Ensure manufacturing compliance with applicable procedures and batch records.
  • Perform real time review of manufacturing batch records.
  • Review manufacturing shop floor documentation.
  • Issue production batch records and product labels to Operations.
  • Routinely recognizes and resolves Quality issues - informs management of proposed solutions.
  • Seeks management guidance on complex issues.
  • Develops procedures.
  • Proposes solutions for complex issues and works with management to resolve.
  • Follows established procedures and performs work as assigned.
  • Builds relationships internally within and with cross functional teams.
  • Contributes to goals within the work group.
  • Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used.
  • Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time.
  • Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

Required Skills:
  • Minimum high school diploma required, with equivalent experience.
  • Bachelor's degree with 4+ years of relevant work experience preferred
  • Aseptic experience preferred, but not required.
  • Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.
  • Background in use of electronic batch record.
  • Quality assurance on the shop floor.
  • Manufacturing background w/QA background.
  • Work in a cleanroom environment.
  • Excellent communication skills must have clear, concise speech (will be wearing a mask as part of the cleanroom PPE).
  • Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Must possess an independent mindset.
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
  • Work is self-directed.
  • Confident in making decisions for non-routine issues.
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
  • Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
  • Understands continuous improvement and improves efficiency and productivity within the group or project.
  • Able to recognize conflict and notify management with proposed recommendations for resolution.
  • Able to prepare written communications and communicate problems to management with clarity and accuracy.
  • Able to effectively multi-task.
  • Knowledge of US and global cGMP requirements.
  • Excellent verbal and written communication skills.
  • Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
  • Must be skilled in planning and organizing, decision-making, and building relationships.
  • Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
  • Must be able to work in the cleanroom environment for 6-hour time periods.
  • Must be available for weekend and off-shift hours.
  • Must be flexible for shift hour changes to support manufacturing.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Purvi: purvi@alphaconsulting.Com


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Purvi Joshi

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